14 results
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19ms
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Sources: EU EUDAMED, US FDA
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950026593·LATEX TUBING 1/4"X1/16" AMBER 50' RL NS W/L
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032958·Baltic Denture System BDLoad Sw6 PLSEbm6DFs C1 ...
Lingual Sheaths
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746156977·WELD LINGUAL SHEATH UR 036 SLOTTED R7M W/DIST I...
ADVANCE(R) II COCR TIBIAL BASE
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code HRY·October 1, 2018
SHAPEABLE DOPPLER FLOW PROBE
FDA 510(k)
FDA Class 2
·Radiology
BREATHING CIRCUIT FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 15, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 3, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 29, 2011
SCORPION SUTURE PASSER, 16MM
FDA Adverse Event
Other
·ARTHREX, INC.·Product code GAB·April 22, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 17, 2019
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024